The efficacy of Botulinum Toxin A for spasticity and pain in adults: A systematic review and meta-analysis using the Grades of Recommendation, Assessment, Development and Evaluation approach

Clinical Rehabilitation

Volumn 27, Issue 12, 2013, Pages 1084-1096

  Baker, Jennifer A ^a   Pereira, Gavin ^b  

^a POOLE HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

Author keywords

Botulinum toxin; GRADE; systematic review

Indexed keywords

BOTULINUM TOXIN; BOTULINUM TOXIN A; NEUROTOXIN;

ADULT; BIBLIOGRAPHIC DATABASE; GRADE; HUMAN; LIMB; META ANALYSIS; PAIN; PATHOPHYSIOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SPASTICITY; SYSTEMATIC REVIEW;

BOTULINUM TOXIN; GRADE; SYSTEMATIC REVIEW;

ADULT; BOTULINUM TOXINS, TYPE A; DATABASES, BIBLIOGRAPHIC; EXTREMITIES; HUMANS; MUSCLE SPASTICITY; NEUROTOXINS; PAIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84887569137     PISSN: 02692155     EISSN: 14770873     Source Type: Journal    
DOI: 10.1177/0269215513491274     Document Type: Review

References (71)

1. Bhakta BB, Cozens JA, Chamberlain MA, et al. Impact of botulinum toxin Type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 ; 69: 217-221
2. Stevenson VL. Spasticity management. Clin Rehabil. 2010 ; 24: 293-304
3. Brashear A, Lambeth K. Spasticity. Curr Treat Options Neurol. 2009 ; 11: 153-161
4. Wissel J, Ward A, Erztgaard P, et al. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med. 2009 ; 41: 13-25
5. Thompson A, Jarrett L, Lockley L, et al. Clinical management of spasticity. J Neurol Neurosurg Psychiatry. 2005 ; 76: 459-463
6. Turkel C, Bowen B, Liu J, et al. Pooled analysis of the safety of botulinum toxin type A in the treatment of poststroke spasticity. Arch Phys Med Rehabil. 2006 ; 87: 786-792
7. Bakheit AMO. Optimising the methods of evaluation of the effectiveness of botulinum toxin treatment of post stroke muscle spasticity. J Neurol Neurosurg Psychiatry. 2004 ; 75: 665-666
8. Spasticity in adults: Management using botulinum toxin. National guidelines. London: RCP ; 2009.
9. Rawicki B, Sheean G, Fung VSC, Goldsmith S, Morgan C, Novak I. Botulinum toxin assessment, intervention and aftercare for paediatric and adult niche indications including pain: international consensus statement. Eur J Neurol. 2010 ; 17 (S2). 122-134
10. Grading quality of evidence and strength of recommendations. BMJ. 2004 ; 328: 1490-1497
11. Harbour R, Miller J. A new system for grading recommendations in evidence based guidelines. BMJ. 200 (323). 334-336
12. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 201 (64). 395-400
13. Guyatt GH, Oxman AD, Akl EA, et al. GRADE guidelines:1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011 ; 64: 383-394
14. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 ; 336: 924-926
15. Cardoso E, Rodrigues B, Lucena R, et al. Botulinum toxin type A for the treatment of the upper limb spasticity after stroke - a meta analysis. Arq Neuropsiquiatr. 2005 ; 63 (1). 30-33
16. Rosales RL, Chua-Yap AS. Evidence based systematic review on the efficacy and safety of botulinum toxin A therapy in post stroke spasticity. J Neural Transm. 2008 ; 115: 617-623
17. Van Kuijk AA, Geurts ACH, Bevaart BJW, van Limbeek J. Treatment of upper extremity spasticity in stroke patients by focal neuronal or neuromuscular blockade: a systematic review of the literature. J Rehabil Med. 2002 ; 34: 51-61
18. Simpson DM, Gracies J-M, Graham HK, et al. Assessment: Botulinum neurotoxin for the treatment of spasticity (an evidence based review): Report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology. Neurology. 2008 ; 70: 1691-1698
19. Garces K, McCormick A, McGahan L, Skidmore B Botulinum toxin A upper and lower limb spasticity: a systematic review. Ottawa: Canadian Coordinating Office for Health Technology Assessment ; 2005 :
20. Olver J, Esquenazi A, Fung VSC, Singer BJ, Ward AB. Botulinum toxin assessment, intervention and aftercare for lower limb disorders of movement and muscle tone in adults: international consensus statement. Eur J Neurol. 2010 ; 17 (S2). 57-73
21. Singh JA, Fitzgerald PM. Botulinum toxin for shoulder pain (review). The Cochrane Collaboration. 2011 ; (Issue 1). 1-51
22. Lance J.W Symposium synopsis. Spasticity disordered motor control. Feldman R Young R Koella W, ed. 1980: 485-494.
23. Balshem H, Helfand M, Schunemann HJ, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 ; 64: 401-406
24. Guyatt GH, Oxman AD, Vist G, et al. GRADE guidelines: 4. Rating the quality of evidence-study limitations (risk of bias). J Clin Epidemiol. 2011 ; 64: 407-415
25. Guyatt GH, Oxman AD, Montori V, et al. GRADE guidelines: 5. Rating the quality of evidence-publication bias. J Clin Epidemiol. 2011 ; 64: 1277-1282
26. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 6. Rating the quality of evidence- imprecision. J Clin Epidemiol. 2011 ; 64: 1283-1293
27. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guideline: 7. Rating the quality of evidence-inconsistency. J Clin Epidemiol. 2011 ; 64: 1294-1302
28. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 8. Rating the quality of evidence-indirectness. J Clin Epidemiol. 2011 ; 64: 1303-1310
29. Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol. 2011 ; 64: 1311-1316
30. GRADE working group. http://www.gradeworkinggroup.org/index.htm (accessed May 2012).
31. Cochrane Handbook for systematic reviews of Interventions. Higgens JPT Green S, ed. The Cochrane Collaboration ; 2011 2011 :
32. De Boer KS, Arwert HJ, De Groot JH, et al. Shoulder pain and external rotation in spastic hemiplegia do not improve by injection of botulinum toxin A into the subscapular muscle. J Neurol Neurosurg Psychiatry. 2008 ; 79: 581-583
33. Kong K-H, Neo J-J, Chua SG. A randomized controlled study of botulinum toxin A in the treatment of hemiplegic shoulder pain associated with spasticity. Clin Rehabil. 2007 ; 21: 28-35
34. Rodgers H, Shaw L, Price C, et al. BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A. Health Technol Assess. 2010 ; 14 (26). 1-141
35. Suputtitada A, Suwanwela NC. The lowest effective dose of botulinum A toxin in adult patients with upper limb spasticity. Disabil Rehabil. 2005 ; 27 (4). 176-184
36. McCrory P, Turner-Stokes L, Baguley IJ, et al. Botulinum toxin A for treatment of upper limb spasticity following stroke: a multi centre randomised placebo controlled study of the effects on quality of life and other person-centred outcomes. J Rehabil Med. 2009 ; 41: 536-544
37. Bakheit AMO, Thilman AF, Ward AB, et al. A randomised, double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin Type A (Dysport) with placebo in upper limb spasticity after stroke. Stroke. 2000 ; 31: 2402-2406
38. Bakheit AMO, Pittock S, Moore AP, et al. A randomized, double blind, placebo controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. J Neurol. 2001 ; 8: 559-565
39. Childers MK, Brashear A, Jozefczyk P, et al. Dose-dependent response to intramuscular botulinum toxin type A for upper limb spasticity in patients after stroke. Arch Phys Med Rehabil. 2004 ; 85: 1063-1069
40. Simpson DM, Alexander DN, O'Brien CF, et al. Botulinum toxin type A in the treatment of upper extremity spasticity: a randomised, double blind, placebo controlled trial. Neurology. 1996 ; 46: 1306-1310
41. Yelnik AP, Colle FM, Bonan IV, Vicout E. Treatment of shoulder pain in spastic hemiplegia by reducing spasticity of the subscapular muscle: a randomised, double blind, placebo controlled study of botulinum toxin A. J Neurol Neurosurg Psychiatry. 2007 ; 78: 845-848
42. Marco E, Duarte E, Vila J, et al. Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double blind randomized clinical trial. J Rehabil Med. 2007 ; 39: 440-447
43. Hesse S, Reiter F, Konrad M, Jahnke MT. Botulinum toxin type A and short term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomised, double blind, placebo controlled trial. Clin Rehabil. 1998 ; 12: 381-388
44. Marciniak CM, Harvey RL, et al. Does Botulinum Toxin type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity. Am J Phys Med Rehabil. 2012 ; 91 (12). 1007-1019
45. Rosales RL, Kong KH, Goh KJ, et al. Botulinum Toxin injection for hypertonicity of the upper extremity within 12 weeks after stroke: A randomised controlled trial. Neurorehabil Neural Repair. 2012 ; 26 (7). 812-821
46. Lam K, Lau KK, So KK, et al. Can Botulinum Toxin decrease carer burden in long tern care residents with upper limb spasticity? A randomised controlled study. J Am Med Dir Assoc. 2012 ; 13: 477-484
47. Hyman N, Barnes M, Bhakta B, et al. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomized, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry. 2000 ; 68: 707-712
48. Pittock SJ, Moore AP, Hardiman O, et al. A double blind randomized placebo controlled evaluation of three doses of botulinum toxin type A (Dysport) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis. 2003 ; 15: 289-300
49. Gusev YI, Banach M, Simonow A, et al. Efficacy and safety of Botulinum toxin Type A Toxin in Adductor spasticity due to Multiple Scelrosis. J Musculoskelet Pain. 2008 ; 16 (3). 175-188
50. Dunne JW, Gracies J-M, Hayes M, Zeman B, Singer BJ. A prospective, multicenter, randomized, double-blind, placebo-controlled trial of onabotulinumtoxinA to treat plantarflexor/invertor overactivity after stroke. Clin Rehabil. 2012 ; 26 (9). 787-797
51. Richardson D, Sheean G, Werring D, et al. Evaluating the role of botulinum toxin in the management of focal hypertonia in adults. J Neurol Neurosurg Psychiatry. 2000 ; 69: 499-506
52. Brashear A, Gordon MF, Elovic E, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 ; 347 (6). 395-400
53. Jahangir AW, Tan HJ, Norlinah MI, et al. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after stroke. Med J Malaysia. 2007 ; 62 (4). 319-322
54. Smith SJ, Ellis E, White S, et al. A double-blind, placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil. 2000 ; 14: 5-13
55. Kaji R, Osako Y, Suyama K, et al. Botulinum toxin type A in post-stroke upper limb spasticity. Curr Med Res Opinion. 2010 ; 26 (8). 1983-1992
56. Simpson DM, Gracies JM, Yablon SA, Barbano R, Brashear A. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo controlled study. J Neurol Neurosurg Psychiatry. 2009 ; 80: 380-385
57. Meythaler JM, Vogtle L, Brunner RC. A preliminary assessment of the benefits of the addition of botulinum toxin A to a conventional therapy program on the function of people with longstanding stroke. Arch Phys Med Rehabil. 2009 ; 90: 1453-1461
58. Wolf SL, Milton B, Reiss A, Easley KA, Shenvi NV, Clark PC. Further assessment to determine the additive effect of Botulinum Toxin type A on an upper extremity exercise program to enhance function among individuals with chronic stroke but extensor capability. Arch Phys Med Rehabil. 2012 ; 93 (4). 578-587
59. Hesse S, Mach H, Frohlich S, Behrend S, Werner C, Melzer I. An early Botulinum Toxin A treatment in subacute stroke patients may prevent a disabling finger flexor stiffness six months later: A randomised controlled trial. Clin Rehabil. 2012 ; 26 (3). 237-245
60. Bhakta BB, O'Connor RJ, Cozens JA. Associated Reactions after stroke: a randomised controlled trial of the effect of botulinum toxin type A. J Rehabil Med. 2008 ; 40: 36-41
61. Cousins E, Ward A, Roffe C, Rimington L, et al. Does low dose botulinum toxin help the recovery of arm function when given early after stroke? A phase II randomised controlled pilot study to estimate effect size. Clin Rehabil. 2010 ; 24: 501-513
62. Maanum G, Jahnsen R, Stanghelle JK, et al. Effects of botulinum toxin A in ambulant adults with spastic cerebral palsy: a randomised double blind placebo controlled trial. J Rehabil Med. 2011 ; 43: 338-347
63. Kaji R, Osako Y, Suyama K, et al. Botulinum toxin type A in post stroke lower limb spasticity: a multicenter, double blind, placebo controlled trial. J Neurol. 2010 ; 257: 1330-1337
64. Burbaud P, Wiart L, Dubos JL, et al. A randomised, double blind, placebo controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry. 1996 ; 61 (3). 265-269
65. Verplancke D, Snape S, Salisbury CF, et al. A randomized controlled trial of botulinum toxin on lower limb spasticity following acute acquired severe brain injury. Clin Rehabil. 2005 ; 19: 117-125
66. Snow BJ, Tsui JKC, Bhatt MH, Varelas M, Hashimoto SA, Calne DB. Treatment of spasticity with botulinum toxin: a double blind study. Annals Neurol. 1990 ; 28 (4). 512-515
67. Sheean G, Lannin NA, Turner-Stokes L, Rawicki B, Snow BJ. Botulinum toxin assessment, intervention and after-care for upper limb hypertonicity in adults: international consensus statement. Eur J Neurol. 2010 ; 17 (S2). 74-93
68. Wissel J, Muller J, Dressnandt J, et al. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 ; 20 (1). 44-49
69. Patrick E, Ada L. The Tardieu scale differentiates contracture from spasticity whereas the Ashworth scale is confounded by it. Clin Rehabil. 2006 ; 20: 173-182
70. Malhotra S, Cousins E, Ward A, et al. An investigation into the agreement between clinical, biomechanical and neurophysiological measures of spasticity. Clin Rehabil. 2008 ; 22: 1105-1115
71. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA Statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009 ; 151: W65 - W94